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Antisense Oligonucleotide

Pelacarsen for Cardiovascular Disease

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Established ASCVD disease defined as documented: Coronary heart disease (CHD) and/or Cerebrovascular disease (CVD) and/or Peripheral arterial disease (PAD)
Be older than 18 years old
Must not have
Uncontrolled hypertension
Heart failure New York Heart Association (NYHA) class IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

Summary

This trial is testing a new drug called pelacarsen to see if it is effective and safe for Black/African American and Hispanic individuals with heart disease and high levels of Lp(a). Participants

Who is the study for?
This trial is for US Black/African American and Hispanic individuals aged 18 to 80 with high Lp(a) levels and existing cardiovascular disease. They must be on stable standard treatments for other risk factors like LDL cholesterol, blood pressure, and diabetes.
What is being tested?
The study tests the effectiveness of Pelacarsen (TQJ230), a medication given as an injection once a month, against a placebo in reducing cardiovascular risk by lowering Lp(a) levels in participants.
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, potential liver issues due to lipid changes, fatigue or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of heart or blood vessel disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is not controlled by medication.
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I have severe heart failure (NYHA class IV).
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I have had cancer in any part of my body before.
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I have had a major bleeding event or a stroke caused by bleeding.
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I have liver disease or my liver isn't working properly.
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I have a serious kidney condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in log-transformed Lp(a) concentration from baseline at week 52
Secondary outcome measures
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest
Incidence proportion of study discontinuations due to TEAEs

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TQJ230Experimental Treatment1 Intervention
TQJ230 80mg QM s.c.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TQJ230
2019
Completed Phase 3
~8330

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,604 Total Patients Enrolled
~267 spots leftby Mar 2027
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